| Class 2 Device Recall GE NM/CT 860 | |
Date Initiated by Firm | December 10, 2020 |
Create Date | January 13, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0854-2021 |
Recall Event ID |
87023 |
510(K)Number | K173816 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. |
Code Information |
Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, 860Z62031 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | GE Healthcare Service 800-437-1171 |
Manufacturer Reason for Recall | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. |
FDA Determined Cause 2 | Process control |
Action | The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative. |
Quantity in Commerce | 12 units |
Distribution | Worldwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = KPS
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